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The aim of the study is to demonstrate the non-inferiority in terms of acute bronchodilator effect between a single dose of CHF 1535 NEXThaler 200/6 µg and a single dose of CHF 1535 NEXThaler 100/6 µg at two dose levels in partially controlled and uncontrolled asthmatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF1535 NEXThaler 100/6, 1 puff | Active Comparator | Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg |
|
| CHF1535 NEXThaler 100/6 µg, 4 puffs | Active Comparator | Beclometasone Dipropionate 400 µg + Formoterol Fumarate 24 µg |
|
| CHF1535 NEXThaler 200/6 µg, 1 puff | Experimental | Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg |
|
| CHF1535 NEXThaler 200/6 µg, 4 puffs | Experimental | Beclometasone Dipropionate 800 µg + Formoterol Fumarate 24 µg |
|
| Placebo NEXThaler | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Area under the curve | FEV1= Forced expiratory volume in the first second of expiration | until 12 h post dose |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 peak | Maximum FEV1 value | until 12 h post dose |
| FVC area under the curve | FVC = Forced Vital Capacity | until 12 h post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Medicines Research | London | NW10 7EW | United Kingdom | |||
| Respiratory Clinical Trials, Hearth Lung Centre |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D001507 | Beclomethasone |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg | Drug |
|
| Placebo | Drug |
|
| FVC peak | Maximum FVC | until 12 h post dose |
| Adverse events | from the signature of the informed consent until the end of the study, the total duration depends on the duration of the run-in and wash-out periods. | over a period of 5 to 14 weeks |
| London |
| W1G 8HU |
| United Kingdom |
| Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013258 | Steroids, Chlorinated |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |